FDA Advances Clinical Study Report Transparency Program

Janet Woodcock

Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER)

The U.S. Food and Drug Administration (FDA) hopes a new clinical trial summary pilot program will better assess whether focusing on particular aspects of clinical study reports (CSRs) from sponsors will provide additional transparency of agency reviews.

The first summary is based on data culled from Janssen’s Erleada (apalutamide), indicated for patients with prostate cancer that has not spread.

Along with the sponsor’s full CSR, the agency includes complete summaries of study results, protocols and protocol amendments, and statistical plans for all pivotal studies supporting the approval.

The pilot will post the CSRs from up to nine New Drug Applications (NDAs) from participating sponsors that have been approved by FDA, says Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER). It’s part of an effort to ensure information accuracy to give patients and healthcare providers a better sense of how FDA makes regulatory decisions. To protect proprietary information, FDA will redact the reports.

Once the pilot is complete, FDA will seek comments from stakeholders on the usefulness of the information presented. The agency hopes that reviewing the CSRs will help the scientific community better understand the information the FDA used to evaluate the NDAs and make approval decisions.

“The exchange of information that [supports] decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively [is] a critical part of enabling the development and dissemination of new medical technology,” says FDA Chairman Scott Gottlieb, MD. “Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.”

For more information, visit https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm589210.html.

Author: Michael Causey